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WASHINGTON: A panel of external advisers from the US Food and Drug Administration on Thursday (December 17) overwhelmingly endorsed the emergency use of Moderna’s coronavirus vaccine, virtually guaranteeing a second choice for protect against COVID-19 in a nation devastated by the pandemic.
The committee voted 20-0 with one abstention that the benefits of the vaccine outweigh its risks in people 18 and older, a week after the same panel endorsed a similar vaccine from Pfizer and its German partner BioNTech, which led to an emergency use authorization from the FDA (USA) one day later.
The FDA is expected to grant the EUA as early as Thursday or Friday night, providing another ray of hope to a nation that has lost more than 300,000 lives to COVID-19, including a one-day high of 3,580 deaths on Wednesday, while the record number of patients threatens to overwhelm US hospitals and healthcare workers.
“Going from having one (genetic) sequence of a virus in January to having two vaccines available in December is a remarkable achievement,” said Dr. James Hildreth, executive director of Meharry Medical College, who voted to recommend the vaccine for use by emergency.
The only abstention came from Dr. Michael Kurilla, who works at the National Institutes of Health and felt that the blanket authorization for those over 18 was too broad.
“I am not convinced that for all those age groups the benefits outweigh the risk. And I would rather see it more targeted at people at high risk of serious and life-threatening COVID disease,” he said.
The Moderna vaccine will begin shipping as soon as the FDA gives the green light. Health and Human Services Secretary Alex Azar told CNBC on Thursday that 5.9 million doses have been allocated for states and large cities and are ready to ship nationwide.
READ: Pfizer-BioNTech, Moderna and Sinovac: A Look at Three Key COVID-19 Vaccines
However, vaccines are not a panacea, as they will take months to implement in a nation where the virus is spreading and public health measures such as social distancing and the use of masks are being rejected by much of the population.
EASIER TO TRANSPORT AND STORE
Unlike Pfizer’s vaccine, which presents complex distribution challenges due to its need to be shipped and stored at -70 degrees Celsius, Moderna’s vaccine does not require specialized ultra-cold freezers or large amounts of dry ice, making it easy to supply in rural and remote areas.
US officials have said they expect to have 40 million doses of the Pfizer / BioNTech and Moderna vaccines by the end of the year, enough to inoculate 20 million people. Both vaccines were about 95 percent effective in preventing disease in pivotal clinical trials without serious safety concerns.
The first wave of doses is expected to go to healthcare workers treating COVID-19 patients and vulnerable residents and nursing home staff.
READ: First data shows that two doses of Oxford-AstraZeneca’s COVID-19 vaccine elicited a good immune response
Papers prepared by FDA scientists and released prior to the meeting said that a two-dose regimen of Moderna vaccine was highly effective in preventing COVID-19 and did not pose any specific safety concerns.
Perhaps even more significantly, as hospital intensive care units fill to capacity across the country, there were no cases of severe COVID-19 among those who received the vaccine in the trial versus 30 such cases in the placebo group.
The vaccine, based on the new synthetic messenger RNA (mRNA) technology, is administered in two injections approximately 28 days apart. The Pfizer-BioNTech injection is also an mRNA vaccine.
In August, the United States signed a $ 1.5 billion pact with Moderna to purchase 100 million doses of its vaccine.
Around 20 million doses are expected to be delivered this month, with the remainder of the initial purchase coming in the first quarter of next year. Last week Moderna agreed to administer an additional 100 million doses in the second quarter.
In the global race to produce highly effective vaccines against the coronavirus that emerged in central China late last year, the Massachusetts-based biotech company has hit the mark ahead of some much bigger rivals like AstraZeneca and Johnson. & Johnson.
An emergency meeting of an advisory panel from the US Centers for Disease Control and Prevention is expected to follow the FDA clearance of Moderna’s vaccine with its official recommendation for its use to the American public.
After that, state and local public health authorities will begin administering the first doses.
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